BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2963172 · Received February 13, 2013

    Report

    Report Number
    2916596-2013-00182
    Event Type
    Death
    Date Received
    February 13, 2013
    Date of Event
    August 28, 2012
    Report Date
    January 18, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE MFR'S CLINICAL REP THAT WHEN REVIEWING PT UPDATES, THE PT HAD EXPIRED. IT WAS NOTED IN THE RECORDS THAT THE PT HAD SUSPECTED PUMP THROMBUS WITH HEMOLYSIS, BLOOD IN URINE. LACTATE DEHYDROGENASE (LDH) OF 4100 AND HAD BEEN GIVEN HEPARIN GTT AND SUFFERED A HEMORRHAGIC STROKE. THE PT WAS PUT ON COMFORT CARE AND EXPIRED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63846 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114077

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death